Advanced patient management with composite parameter indices

ABSTRACT

Systems, devices and methods for defining, identifying and utilizing composite parameter indices from health-related parameters are disclosed. One aspect is a programmable device having machine executable instructions for performing a method to assist with managing a patient&#39;s health. In various embodiments, a first set of at least two health-related parameters is acquired. A first composite parameter is generated using the first set of at least two health-related parameters. Other aspects and embodiments are provided herein.

CLAIM OF PRIORITY

This application is a divisional of U.S. application Ser. No.13/162,311, filed Jun. 16, 2011, now issued as U.S. Pat. No. 8,301,252,which is a divisional of U.S. application Ser. No. 10/323,860, filedDec. 18, 2002, abandoned, each of which is hereby incorporated byreference in its entirety.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to the following commonly assigned U.S.patent applications which are herein incorporated by reference in theirentirety: “Method and Apparatus for Establishing Context Among Eventsand Optimizing Implanted Medical Device Performance,” Ser. No.10/093,353, filed on Mar. 6, 2002, now U.S. Pat. No. 7,043,305;“Advanced Patient Management For Acquiring, Trending and DisplayingHealth-Related Parameters,” Ser. No. 10/323,859, filed on Dec. 18, 2002;“Advanced Patient Management For Defining, Identifying and UsingPredetermined Health-Related Events,” Ser. No. 10/323,604, filed on Dec.18, 2002; “Advanced Patient Management For Reporting MultipleHealth-Related Parameters,” Ser. No. 10/323,606, filed on Dec. 18, 2002,now U.S. Pat. No. 7,983,759; “Advanced Patient Management System WithEnvironmental Data,” Ser. No. 10/323,590, filed on Dec. 18, 2002,abandoned; “Advanced Patient Management For Identifying, Displaying AndAssisting With Correlating Health-Related Data,” Ser. No. 10/323,713,filed on Dec. 18, 2002, now U.S. Pat. No. 7,468,032; “Advanced PatientManagement For Triaging Health-Related Data,” Ser. No. 10/323,616, filedon Dec. 18, 2002, abandoned; and “Advanced Patient Management ForTriaging Health-Related Data Using Color Codes,” Ser. No. 10/323,607,filed on Dec. 18, 2002, now U.S. Pat. No. 8,043,213.

TECHNICAL FIELD

This application relates generally to medical devices and, moreparticularly, to advanced patient management that defines, identifiesand utilizes composite parameter indices.

BACKGROUND

An Implantable Medical Device (IMD) is a medical device designed to bechronically implanted in a human or other organism. Some IMDs includesensors to monitor a patient's condition, and some IMDs have been usedto treat a patient. Some examples of IMDs include implantable cardiacrhythm management (CRM) devices such as cardiac pacemakers andimplantable cardioverter/defibrillators (ICDs). Other examples of IMDsinclude a number of monitors or sensors, stimulators and deliverysystems for both cardiac-related applications and non-cardiac-relatedapplications.

The sensed data from the IMD is capable of being wirelessly communicatedto an external device, and the external device is capable of wirelesslyprogramming the IMD. For example, data from an implantable CRM iscapable of being wirelessly communicated to a programmer device.Additionally, the programmer is capable of wirelessly communicating withthe implantable CRM to program the CRM to perform a desired devicefunction.

Due to the potentially large amount of data capable of being sensed byone or more IMDs, it is desired to appropriately process the largeamount of sensed data to provide meaningful information. The sensed dataalone may not be an accurate indication of the overall health of thepatient because other factors can significantly influence the senseddata. Thus, it has been proposed to use patient data from other sources.However, this patient data can compound the problem of providingmeaningful data, and still may not provide an accurate indication of theoverall health of the patient.

SUMMARY

The above mentioned problems are addressed by the present subject matterand will be understood by reading and studying the followingspecification. The present subject matter provides for defining,identifying and utilizing composite parameter indices generated fromhealth-related parameters acquired from a variety of sources, includingdata provided by an implanted medical device (IMD) and from othersources.

One aspect is a programmable device having machine executableinstructions for performing a method to assist with managing a patient'shealth. In various embodiments, a first set of at least twohealth-related parameters is acquired. A first composite parameter isgenerated using the first set of at least two health-related parameters.

These and other aspects, embodiments, advantages, and features willbecome apparent from the following description and the referenceddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an advanced patient management (APM) system accordingto various embodiments of the present subject matter.

FIG. 2 illustrates an advanced patient management (APM) system accordingto various embodiments of the present subject matter.

FIG. 3 illustrates an advanced patient management (APM) system havingdirect communication links according to various embodiments of thepresent subject matter.

FIG. 4 illustrates an advanced patient management (APM) system havingnetwork communication links according to various embodiments of thepresent subject matter.

FIG. 5 illustrates an advanced patient management (APM) system havingnetwork communication links according to various embodiments of thepresent subject matter.

FIG. 6 illustrates a perspective view of an advanced patient management(APM) system that includes an IMD and a portable device such as a PDA.

FIG. 7 illustrates a perspective view of an advanced patient management(APM) system that includes an IMD, a portable device such as a PDA, andanother wellness monitoring device, such as a programmer for the IMD,networked to the PDA.

FIG. 8 illustrates a perspective view of an advanced patient management(APM) system that includes an IMD, a portable device such as a PDA, andanother wellness monitoring device, such as a programmer for the IMD,directly connected to the PDA.

FIG. 9 illustrates a block diagram of an IMD according to variousembodiments of the present subject matter.

FIG. 10 illustrates a block diagram of a wellness monitoring device,such as a portable device, according to various embodiments of thepresent subject matter.

FIG. 11 illustrates various embodiments of a wellness monitoring device(WMD) in the form of a general-purpose computing device.

FIG. 12 illustrates a block diagram of an advanced patient managementsystem for acquiring, trending and displaying multiple health-relatedparameters according to various embodiments of the present subjectmatter.

FIG. 13 illustrates a block diagram of a wellness trending displaygenerally illustrating parameter trends available for display accordingto various embodiments of the present subject matter.

FIG. 14 illustrates a block diagram of a wellness trending displayillustrating an arrangement for selecting and displaying parametertrends according to various embodiments of the present subject matter.

FIG. 15 illustrates an example of a wellness trending display.

FIG. 16 illustrates a block diagram according to various aspects of thepresent subject matter in which a diagnostic context is provided toassist with interpreting the health condition of the patient, and toappropriately adjust the device and/or medical therapy, accordingly.

FIG. 17 illustrates a method for managing a patient's health bydefining, detecting and using predetermined health-related events,according to various embodiments of the present subject matter.

FIG. 18 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of detecting predeterminedhealth-related events, according to various embodiments of the presentsubject matter.

FIG. 19 illustrates a wellness monitoring device (WMD) for monitoring apatient's health condition that is capable of detecting predeterminedhealth-related events, according to various embodiments of the presentsubject matter.

FIG. 20 illustrates a method for reporting multiple parameters relatedto a health condition of a patient, according to various embodiments ofthe present subject matter.

FIG. 21 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of prioritizing communicationof health-related parameters, according to various embodiments of thepresent subject matter.

FIG. 22 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of synthesizing environmentalparameters with IMD parameters, according to various embodiments of thepresent subject matter.

FIG. 23 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of correlating trendedparameters, predetermined events, and alerts, according to variousembodiments of the present subject matter.

FIG. 24 illustrates a method to generate composite parameters for use inmanaging a patient's health, according to various embodiments of thepresent subject matter.

FIG. 25 illustrates a method to generate composite parameters for use inmanaging a patient's health, according to various embodiments of thepresent subject matter.

FIG. 26 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of generating compositeparameters, according to various embodiments of the present invention.

FIG. 27 illustrates a method to triage predetermined events for use inmanaging a patient's health, according to various embodiments of thepresent subject matter.

FIG. 28 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of classifying a number ofpredetermined events according to severity, and performing a systemaction based on the classification, according to various embodiments ofthe present subject matter.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description refers to the accompanying drawingswhich show, by way of illustration, specific aspects and embodiments inwhich the present subject matter may be practiced. These embodiments aredescribed in sufficient detail to enable those skilled in the art topractice the present subject matter. Other embodiments may be utilizedand structural, logical, and electrical changes may be made withoutdeparting from the scope of the present subject matter. The variousembodiments disclosed herein are not necessarily mutually exclusive, assome disclosed embodiments can be combined with one or more otherdisclosed embodiments to form new embodiments. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present subject matter is defined only by the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

The present subject matter provides a system to assist with monitoringthe overall health of patients, and thus to assess and treat healthconditions, by acquiring, trending and displaying a number ofhealth-related parameters. In various embodiments, a clinician such as aphysician monitors the patient's health. In various embodiments, thesystem includes an implantable medical device (IMD) which is capable ofsensing various health-related parameters (also referred to herein asinternal health-related parameters) indicative of a health condition.The IMD includes one or more IMD sensors to sense one or more desiredinternal health-related parameters. In various embodiments, the IMD iscapable of providing therapy to treat the health condition. In variousembodiments, the system includes an external health data source thatincludes other health-related parameters (also referred to herein asexternal health-related parameters). The external health-relatedparameters can influence the sensed internal health-related parameters.Thus, a combination of internal and external health-related parameterscan provide a more accurate view of the patient's health.

In various embodiments, the system includes a user input to collecthealth-related information that is contributed voluntarily by a user(such as a patient, clinician or other user). This user-volunteeredinformation is an example of external human-resource parameters and isable to be more subjective in nature (compared to the internalhealth-related parameters determined by sensors or other externalhealth-related parameters such as databases and external sensors), andthus is useful to identify other information that can influence theother health-related parameters. The present subject matter acquiresinternal and/or external health-related parameters from one or more ofthese sources, and generates composite parameter indices to assist withaccurately assessing and treating a patient's health condition. As such,the present subject matter is capable of providing a diagnostic contextused to interpret the health condition of the patient, and toappropriately adjust the device and/or medical therapy, accordingly.

A large number of health-related parameters are capable of beingacquired, trended and displayed according to various embodiments of thepresent subject matter. For example, a non-exhaustive list ofhealth-related parameters includes heart rate/rhythm includingventricular tachycardia and fibrillation, conduction intervals, ectopicdensity, atrial fibrillation (AF)/atrial tachycardia (AT) percent, heartrate variability (HRV), activity, lead position, concomitant conditions,temperature, blood pressure, respiration rate/rhythm,pulmonary/peripheral edema, posture, blood gases, stroke volumecontractility, filling time, heart sounds, weight, ischemia, cardiacoutput, after load, medications, device indications, and electromyogram.Other examples of health-related parameters are provided throughout thisdisclosure.

These health-related parameters are capable of being acquired from anumber of data sources. For example, a non-exhaustive list of datasources include IMDs, external device sensors, medication usagemonitors, databases, and user inputs by a clinician and/or patient. AnIMD, for example, is capable of providing health-related parameters forrhythms, conduction delays, respiration, activity, heart sounds,posture, and the like. External device measurements, for example, arecapable of providing health-related parameters for weight, bloodpressure, echo pulse oximetry, peripheral edema, and the like. Otherexamples of IMD health-related parameters and external health-relatedparameters are provided throughout this disclosure. A physician, forexample, is capable of providing health-related parameters for leadpositions, indications(s), medications, concomitant conditions, and thelike. A medical database, for example, is capable of providinghealth-related parameters from external device measurements andphysician input for medical tests and a large number and a large varietyof other parameters. A patient, for example, is capable of providinghealth-related parameters for diet, medication usage, symptoms, bloodpressure, and the like. As technology continues to improve, more andmore health-related parameters will be automatically acquired using, forexample, an IMD rather than using an external interactive system.

In various embodiments of the present subject matter, the APM systemperforms various methods related to managing a patient's health. The APMsystem includes a number of programmable devices with a machine-readablemedium having machine-executable instructions. The programmabledevices(s) perform the machine-executable instructions to perform themethod. In various embodiments, the programmable device includes aprocessor to perform the machine-executable instructions. In variousembodiments, the machine-executable instructions are provided on one ormore machine-readable mediums (or media).

FIG. 1 illustrates an advanced patient management system according tovarious embodiments of the present subject matter. Various embodimentsof the system 100 include less than all of the components shown in FIG.1, and various embodiments of the system 100 include other componentsthan those shown in FIG. 1.

A patient 101 is illustrated with an implantable medical device (IMD)102. Generally, the IMD includes one or more IMDs that provide internaltherapy and/or acquire or sense internal data parameters. In variousembodiments, the IMD is a CRM device that provides cardiac rhythmmanagement pulsing and also senses one or more physiological parametersof a heart. Other IMDs that sense parameters and/or provide therapy,including various electrical and drug therapy, are within the scope ofthe present subject matter.

In various embodiments, at least one IMD 102 provides internal data suchas heart rhythm, breathing, and activity. Other types of data derivedfrom IMDs are also contemplated. For example, in one embodiment, arespiration sensor is implanted into patient and communicates withportable device. Data received from such IMDs may be perceived asinvoluntary, or passive, data since the patient has no control over theprocess of collecting and transmitting the data from such sources. Invarious embodiments, IMD-provided data includes parameters sensed by theIMD and/or parameters provided by interrogating the IMD to obtain deviceperformance status.

The illustrated system also includes one or more external data source(s)103 that provide health-related parameters. The external health-relatedparameters supplement the internal parameters and/or provide adiagnostic context to the internal health-related parameters. Examplesof external source(s) of health data include: external sensing devicessuch as body temperature thermometers, blood pressure monitors, and thelike; room temperature thermometers, light sensors and the like;databases such as patient history databases that are found hospitals orclinics and that may include information such as medical test resultsand family history; a web server database (a database accessible througha global communication network—e.g. Internet) that may includeinformation regarding environment, medication interaction, and the like;databases and/or user inputs regarding mental/emotional and dietparameter types; and other external data sources capable of providinghealth-related parameters. One definition of the term mental issomething that is of or relates to the mind. One definition of the termemotional is a strong feeling, aroused mental state, or intense state ofdrive or unrest, which may be directed toward a definite object and isevidenced in both behavior and in psychologic changes, with accompanyingautonomic nervous system manifestations.

The illustrated system also includes a user input 104 through which auser is able to input additional health-related parameters for use by awellness monitoring device (WMD) 105. In various embodiments, the userinput 104 includes a touch screen on a PDA or other device, a keyboardand mouse on a computer, and the like. In various embodiments, a patientis able to input additional health-related parameters for use by thewellness monitoring device. In various embodiments, a clinician is ableto input additional health-related parameters for use by the WMD.

The WMD 105 is illustrated by dotted line, and includes one or moredevices. In various embodiments, the at least one IMD 102 communicateswirelessly with at least one WMD 105, as shown by communication link106. In various embodiments that include multiple WMDs, the WMDs areable to communicate with each other, as shown via communication link107. In various embodiments, the WMD(s) includes portable devices 108that are external to the body of patient such as a PDA, (variouslyreferred to as a personal digital, or data, assistant), a portabletelephone (including a cellular telephone or a cordless telephone), apager (one way or two way), a handheld, palm-top, laptop, portable ornotebook computer, or other such battery operated portable communicationdevice. IN various embodiments, the WMD(s) includes programmers. Invarious embodiments, the WMD(s) includes various non-portable devicessuch as larger computers or computer enterprise systems.

In various embodiments of the present subject matter, the WMD 105 (whichincludes one or more devices) includes a display on which parametertrends are capable of being displayed. In various embodiments, theportable device 108 includes a touch-sensitive display screen fordisplaying information to a user or patient. Depending on theapplication executing on the portable device 108, the display screen mayprovide prompts, messages, questions, or other data designed to elicitan input from patient. Examples of such prompts are provided in thepatent application entitled “Method and Apparatus for EstablishingContext Among Events and Optimizing Implanted Medical DevicePerformance,” Ser. No. 10/093,353, filed on Mar. 6, 2002, now U.S. Pat.No. 7,043,305, which has previously been incorporated by reference inits entirety. Data received from such interactive prompts may beperceived as voluntary, or active, data since the cooperation and activeinput of the patient is part of the data collection process. In variousembodiments, the user input data may be received from a user based on aprompt provided to the user, on an ad hoc basis as determined by theuser, or as determined by a processor. The user may enter data using amenu based system, a graphical user interface (GUI), textual data ornumerical data.

The WMD provides analysis of internal and external (both voluntary andinvoluntary) parameters. In various embodiments, the WMD includescomputer and programming that conducts data analysis suitable for use inmanaging patient health and medical care.

FIG. 2 illustrates an advanced patient management (APM) system accordingto various embodiments of the present subject matter. Variousembodiments of the system 200 include all of the components shown inFIG. 2, various embodiments of the system 200 include less than all ofthe components shown in FIG. 2, and various embodiments of the system200 include other components than those shown in FIG. 2.

In the figure, the system 200 is shown to include an IMD 202. In variousembodiments, the IMD includes an implantable cardiac device (ICD),cardiac rhythm management (CRM) device, pulse generator, or otherimplanted medical device that provides therapy to a patient or an organof a patient, and/or that provides data derived from measurementsinternal to a patient. In various embodiments, the IMD includes a deviceto provide drug therapy.

The illustrated system 200 includes at least one WMD 205 that includesat least one display for displaying trended parameters. In theillustrated system, the at least one WMD includes a portable device 208(such as a PDA) and a programmer 209. The IMD 202 is shown coupled tothe portable device 208 by communication link 210. The portable deviceis further coupled to the programmer by communication link 207. Variousembodiments of the present subject matter do not include the portabledevice 208. In these embodiments, the IMD 202 is able to be coupleddirectly to the programmer 209 by a communication link (not shown).

At least one external data source 203 (such as web server(s),database(s), and sensor(s)) is coupled to the WMD(s) via at least onecommunication link. The external data source 203 provides external (withrespect to the IMD in the patient) health-related parameters thatsupplement and/or provide context for the IMD parameters. In theillustrated system, a communication link 211 exists between the portabledevice 208 and the external data source 203, and a communication link212 exists between the programmer 209 and the external data source 203.It is noted that various applications may not require both communicationlinks 211 and 212. In the illustration, the system 200 includes at leastone user input 204 to the at least one WMD 205. For example, a patientis able to provide health-care information using the portable device208, and a health care provider is capable of providing health-careinformation using the programmer 209.

In various embodiments, the IMD also includes circuitry and programmingadapted to monitor the condition and performance of the pulse generatoror other IMD. For example, in various embodiments, the IMD provides dataconcerning the remaining battery condition for a power supply coupled tothe IMD. Such data may include information regarding remaining batterycapacity or life, battery internal resistance or other measurableparameters. In various embodiments, the data includes informationregarding the electrical therapy provided by the IMD. For example, invarious embodiments, such data includes lead impedance, sense voltagelevels, therapy history, and device therapy mode settings and parametervalues. In various embodiments, the IMD provides data regarding dosage,timing and other functions regarding the delivery of a drug therapy orother therapy. For example, in various embodiments, the IMD monitorsblood sugar levels and the amount and timing of insulin delivered to thepatient.

In various embodiments, the IMD includes a program executing on aninternal processor that controls the operation of the IMD. The programinstructions reside in a memory accessible to the internal processor. Bychanging the program, or memory contents, the present system allows theoperating program of the IMD to be dynamically tailored to a particularpatient or condition. In various embodiments, the operating system, ormemory contents of the IMD is changed using wireless communication.

In various embodiments, the IMD includes a wireless transceiver. Thetransceiver operates using radio frequency transmissions,electromagnetic transmissions, magnetic coupling, inductive coupling,optical coupling, or other means of communicating without need of a wireconnection between the IMD and another transceiver.

In various embodiments, the IMD performs a data acquisition function. Invarious embodiments, the IMD is adapted to monitor a fluid pressure,such as blood or urine. In various embodiments, the detector is adaptedto monitor respiration, stress level, or other measurable biometricparameter. In various embodiments, monitoring includes determining anabsolute or relative value for a particular biometric parameter. Invarious embodiments, internal memory within the IMD stores a comparisonvalue which may then be compared with a measured value therebydetermining the performance of the IMD or the health of the patient.

In various embodiments, the communication link includes a wirelesscommunication link between the IMD and portable device. Thecommunication link allows communication in one or two directions.

In various embodiments, data from the IMD is communicated to portabledevice with no data transmitted from portable device to the IMD. In thismanner, portable device functions as a data storage facility for theIMD. In various embodiments, data stored in portable device is accessedby a treating physician and used for diagnosis, therapy or otherpurposes. Programming and controlling the operation of the IMD isperformed using a programmer adapted to transmit commands, data or codeto the IMD. In various embodiments, portable device executes programmingto analyze and process the data received from the IMD. In variousembodiments, communication link precludes transfer of data from portabledevice to the IMD or precludes transfer of data from the IMD to portabledevice. For example, it may be desirable in certain circumstances toprevent the portable device from executing programming to automaticallyadjust the performance or operation of the IMD independent of aprogrammer.

In various embodiments, data is communicated from portable device to theIMD with no data transmitted from the IMD to portable device. In thismanner, portable device functions as an interface to communicatecommands, data or code to the IMD. In various embodiments, data iscommunicated from the IMD to the portable or external device with nodata transferred from the device to the IMD.

In various embodiments, data is communicated bidirectionally between theIMD and the portable device. In various embodiments, the communicationlink between the IMD and the portable device entails a singlebidirectional communication channel or includes multiple unidirectionalcommunication channels which, when viewed as a whole, providebidirectional communication. In various embodiments, a unidirectionalcommunication channel operates using a particular frequency orcommunication protocol. For example, the link may include a wirelessradio frequency link compatible with a transmitter and receiver thatuses frequency hopping, spread spectrum technology.

In various embodiments, internal memory within the IMD provides storagefor data related to the IMD-provided therapy (such as CRM therapyprovided to a heart). For example, the data can relate to theelectrical, chemical or mechanical operation of the heart. In addition,the IMD includes memory for programming, comparison and other functions.In various embodiments, the contents of the memory regulates theoperation of the IMD.

In various embodiments, the portable device 208 includes or otherwise isincorporated or in communication with a battery operated portablecommunicator having a processor, memory, and an output interface tocommunicate with a user and an input interface to receive user entereddata. One suitable example of a portable communicator is that of apersonal digital assistant (PDA). PDA devices typically include adisplay screen for presenting visual information to a user and a writingsurface for entry of data using a stylus. Data can be entered using akeyboard coupled to the portable communicator or by means of a wired orwireless communication link. Some portable communicator models alsoinclude an audio transducer, or sound generator, adapted to producesounds that are audible by a user. In various embodiments, data from theIMD or the programmer is displayed on a display or screen of theportable device.

In various embodiments, the portable device 208 includes or otherwise isincorporated or in communication with a portable telephone (such as acellular telephone or a cordless telephone), a pager (one way or twoway), or a computer (such as a handheld, palm-top, laptop, or notebookcomputer) or other such battery operated, processor based, portablecommunication device.

In various embodiments, the portable device 208 includes data storageand includes programming and instructions to conduct data processing. Invarious embodiments, the data storage capacity of the portable device208 augments the data storage capacity of the IMD 202, thus enabling aclinician to access a greater amount of multi-related informationregarding the medical condition of a user. For example, but not by wayof limitation, the additional information may assist in discovering andunderstanding relationships among different events.

In various embodiments, a wireless receiver is coupled to a portabledevice for purposes of receiving data from the IMD 202 throughcommunication link 210. In various embodiments, a wireless transmitteris coupled to the portable device for purposes of transmitting data tothe IMD. In various embodiments, a wireless transceiver is coupled tothe portable device for purposes of both transmitting data to, andreceiving data from, the IMD. In various embodiments, the portabledevice includes telemetry to facilitate wireless communications.

In various embodiments, circuitry or programming allows the portabledevice 208 to trigger an alarm under predetermined conditions. Invarious embodiments, for example, the portable device sounds an audiblealarm or transmits an alarm signal if a biometric parameter exceeds aparticular value or is outside a specified range of values. The alarmsignal can be received by the programmer 209 or a designated physician.

Communication link 207 couples the portable device 208 with theprogrammer 209. In various embodiments, communication link 207 includesa wired or wireless link that allows data communication between portabledevice and the programmer. In various embodiments, data is exchangedbetween portable device and the programmer by means of a removablestorage media.

In various embodiments, the programmer 209 includes a processor basedapparatus that executes programming to communicate with the IMD 202, theportable device 208, or both. A clinician (e.g. physician) can operatethe programmer to communicate with the IMD using 202 portable device asa data interface. In particular, various embodiments provide that datafrom the IMD 202 can be retrieved by accessing the memory of portabledevice 208. In various embodiments, the programmer 209 transmits data tothe IMD 202 via the portable device 208.

In various embodiments, at least one of the WMDs includes a display.FIG. 2 illustrates a system in which the portable device 208 includes adisplay and the programmer 209 includes a display. According to variousembodiments of the present subject matter, health-related parameters aredisplayed on the display(s) of the wellness monitoring device(s). Invarious embodiments, these health-related parameters are acquired via anIMD and/or via an external source such as user input and/or externalhealth data sources such as databases and the like. According to variousembodiments of the present subject matter, trended health-relatedparameters, predetermined events, alerts and/or other informationprovided in this disclosure are displayed on the wellness monitoringdevice(s).

FIG. 3 illustrates an advanced patient management (APM) system havingdirect communication links according to various embodiments of thepresent subject matter. According to various embodiments of the system300, the communication links include wired links, wireless links or bothwired and wireless links. Various embodiments include all of thecomponents shown in FIG. 3, various embodiments include less than all ofthe components shown in FIG. 3, and various embodiments include othercomponents than those shown in FIG. 3.

The illustrated system 300 includes at least one IMD 302, at least oneexternal source of health data 303, and at least one WMD 305 with adisplay 313. The illustrated system includes a user input 304 tocommunicate with the WMD. The illustrated system includes acommunication link 314 between the IMD(s) 302 and the external source(s)of health-related data 303, a communication link 315 between theexternal source(s) of health-related data 303 and the WMD(s) 305, and acommunication link 316 between the IMD(s) 302 and the WMD(s) 305. It isnoted that various embodiments include less than all of thecommunication links. For example, in various embodiments data from theexternal source(s) of health data is not communicated to IMD(s) throughlink 314, and in various embodiments data from the external source(s) ofhealth data is communicated to the wellness monitor device(s) throughthe IMD(s) and links 314 and 316. Various embodiments implement variouscommunication designs to achieve various data flow.

In various embodiments, the display 313 of the WMD(s) is used to displaytrended parameters, such as internal parameters from the IMD(s) andexternal parameters for the external source(s) of health-related data.Other information can be displayed, as is provided throughout thedisclosure. Furthermore, a user is able to input additional externalhealth-related information via user input. In various embodiments, theWMD(s) include a portable device such as a PDA, laptop computer, cellphone, and the like. In various embodiments, the WMD(s) include otherexternal devices such as bedside monitors, desktop computers, IMDprogrammers, and the like.

FIG. 4 illustrates an advanced patient management (APM) system havingnetwork communication links according to various embodiments of thepresent subject matter. According to various embodiments, thecommunication links include wired links, wireless links or both wiredand wireless links. Various embodiments include all of the componentsshown in FIG. 4, various embodiments include less than all of thecomponents shown in FIG. 4, and various embodiments include othercomponents than those shown in FIG. 4.

The illustrated system 400 includes at least one IMD 402, at least oneexternal source of health data 403, at least one WMD 405 with a display413, and at least one network infrastructure through which the otherdevices (also referred to within this discussion as network devices) arecapable of communicating. The illustrated system includes a user input404 to communicate with the WMD 405. In various embodiments, the WMD(s)includes a portable device such as a PDA, laptop computer, cell phone,and the like. In various embodiments, the wellness monitor device(s)include other external devices such as bedside monitors, desktopcomputers, IMD programmers, and the like. Examples of a networkcommunication link includes, but is not limited to, one or more of thefollowing: cellular telephone coupled to a portable device via theInternet, a private area branch exchange (PABX, also known as a PBX); anintranet network; an ethernet connection or other remote communicationmeans.

The illustrated system includes a communication link between the IMD(s)402 and the external source(s) of health-related data 403 via thenetwork 417, a communication link between the external source(s) ofhealth-related data 403 and the WMD(s) 405 via the network 417, and acommunication link between the IMD(s) and the WMD(s) 405 via the network417. The illustrated system includes a network interface or adapter 418.The network adapter 418 wirelessly communicates with the IMD 402 viacommunication link 419, and communicates with network devices throughnetwork via communication link 420. Although not expressly, othernetwork devices include a network interface.

Various embodiments include a direction communication link asillustrated in FIG. 3 and a network communication link as illustrated inFIG. 4. The display of the WMD(s) is used to display trended parameters,such as internal health-related parameters from the IMD(s) and externalhealth-related parameters for the external source(s) of health-relateddata. Furthermore, a user is able to input additional externalhealth-related information via user input.

FIG. 5 illustrates an advanced patient management (APM) system havingnetwork communication links according to various embodiments of thepresent subject matter. Various embodiments include all of thecomponents shown in FIG. 5, various embodiments include less than all ofthe components shown in FIG. 5, and various embodiments include othercomponents than those shown in FIG. 5.

The illustrated system 500 includes at least one IMD 502, at least oneexternal source of health data 503, at least one WMD 505 with a display513, and at least one network infrastructure 517 through which the otherdevices (also referred to within this discussion as network devices) arecapable of communicating. The illustrated system 500 also includesdirect communication connections 521 between the IMD(s) 502 and theexternal source(s) of the health data 503, and between the WMD(s) 505and the IMDS(s) 502. One of ordinary skill in the art will understand,upon reading and comprehending this disclosure, that various embodimentsinclude some direct communication connections between some componentsand include some network communication connections between somecomponents.

The illustrated external source(s) of health data 503 include at leastone external sensing device 522 such as a body temperature or bloodpressure monitor, at least one patient history database 523, at leastone web server 524, and other external sources 525. Various embodimentsof the present subject matter include one or more of the illustratedexternal sources of health data. The illustrated WMD(s) includes aprogrammer 509 with a display, a portable device 508 (such as a PDA orlaptop computer) with a display, or other WMD(s) 526 with a display.Various embodiments of the present subject matter include one or more ofthe illustrated WMDs.

FIG. 6 illustrates a perspective view of an advanced patient management(APM) system that includes an IMD 602 and a portable device 608 such asa PDA. The illustrated portable device 608 includes a display screen627, a plurality of user operable buttons 628, and an expansion port 629which receives and is coupled to an expansion device 630 that isdesigned to communicate with the IMD 602. In various embodiments, aspecially designed portable device is employed with an integratedcommunication subsystem. A stylus 631 can be used to manually enter datausing screen. Link 606 is illustrated as a bidirectional link and thus,data from IMD 602 is wirelessly telemetered to the portable device 608through the expansion device 630. In addition, data, or programming fromthe portable device 608 is wirelessly telemetered from the expansiondevice 630 to the IMD 602.

According to various embodiments, the portable device (such as theillustrated PDA) generates a prompt at various times calling for aresponse in the form of a user input. A user may enter data using any ofa variety of means. For example, a response may be entered using stylus,buttons, or an external keyboard. In one embodiment, portable deviceresponds to voice commands received from a user. A prompt may bevisually displayed using screen or audibly generated using an internalsound generator. Manually entered data received from a user, as well asdata received from other inputs is stored using the portable device. Thedata stored in the portable device is available for processing, and totailor the therapy.

In addition to data entry, the portable device 608 provides a user withlimited control over the operation of an IMD 602 in various embodiments.In various embodiments, reasonable constraints on the authority tochange the operation of IMD are established and implemented by aclinician.

FIG. 7 illustrates a perspective view of an advanced patient management(APM) system that includes an IMD 702, a portable device 708 such as aPDA, and another WMD 732, such as a programmer for the IMD, networked tothe PDA. The illustrated portable device includes a wirelesscommunication antenna 733. In various embodiments, the portable device708 is adapted for wireless access to Internet network using link 734.In various embodiments, link 734 includes a radio frequencycommunication link. The programmer accesses the Internet via link 735.In various embodiments, 735 link includes a dial-up modem connection, acable modem connection, a DSL connection, an ISDN line, or other channelproviding access to the Internet.

A user is able to compile contextual information regarding IMD 702, aswell as himself, using the portable device 708. In various embodiments,a clinician using the programmer 732 is able to remotely access the datastored in the portable device 708 using link 735, Internet and link 734.In this manner, programmer 732 is able to wirelessly receive the data,process the data, and transmit data and code to change the futureoperation of the IMD 702.

FIG. 8 illustrates a perspective view of an advanced patient management(APM) system that includes an IMD 802, a portable device such as a PDA808, and another WMD 832, such as a programmer for the IMD, directlyconnected to the PDA. The PDA is coupled to IMD by wireless link 836,and is further coupled to programmer by link 837 (illustrated as acommunication cable).

A clinician operating programmer 832 is able to exchange data or codewith the PDA 808 using link 837. Connector is a multi-conductorconnector providing access to data of the PDA. It will be appreciatedthat link may couple the PDA to a local area network or othercommunication network. For example, the PDA may be connected to a publicswitched telephone network (PSTN) link, and thus, programmer mayexchange data with portable communicator using a modem coupled to PSTN.

FIG. 9 illustrates a block diagram of an IMD according to variousembodiments of the present subject matter. The illustrated IMD 902includes a processor 938, memory 939, an update module 940 and atransceiver 941. In operation, the processor governs the operation ofIMD and executes programming stored in memory. In addition to theexecutable program, memory also includes data storage regarding thepatient and IMD. The update module operates in conjunction withprocessor, memory and transceiver to receive, install, and execute newinstructions for execution by processor.

FIG. 10 illustrates a block diagram of a WMD, such as a portable device,a programmer and the like, according to various embodiments of thepresent subject matter. The illustrated WMD 1005 includes long term datastorage 1042, an input/output 1043, a controller 1044, an IMDtransceiver 1045, a communication interface 1046 and a display 1047. Thelong term data storage augments the data storage capacity of the memoryof the IMD. In various embodiments, the storage is of a greater capacitythan that of memory, is physically larger in size, and is less expensiveand more robust than medical grade implantable memory.

The input/output, the IMD transceiver and the communication interface,in conjunction with the controller enables receipt and transmission ofdata from the IMD as well as data from other sources such as other WMDs,databases and the like. The IMD transceiver provides a wirelesscommunication link between the IMD and the portable device. The displayis used to, among other things, display parameters that have beenacquired and trended by the system according to the present subjectmatter.

FIG. 11 provides a brief, general description of a suitable computingenvironment in which the above embodiments may be implemented. Theillustrated computing environment, or portions thereof, can beimplemented in a WMD. Additionally, portions of the illustratedcomputing environment (such as the system memory and processor) can beimplemented in IMDs.

Embodiments of the present subject matter can be described in thegeneral context of computer-executable program modules containinginstructions executed by a computing device. The term module includeshardware, firmware, software, and various combinations thereof toperform task(s) described in this disclosure, as is understood by one ofordinary skill in the art upon reading and comprehending thisdisclosure. Program modules include routines, programs, objects,components, data structures, etc. that perform particular tasks orimplement particular abstract data types. Those skilled in the art willappreciate that the invention may be practiced with othercomputer-system configurations, including hand-held devices,multiprocessor systems, microprocessor-based programmable consumerelectronics, network PCs, minicomputers, mainframe computers, and thelike which have multimedia capabilities. The invention may also bepracticed in distributed computing environments where tasks areperformed by remote processing devices linked through a communicationsnetwork. In a distributed computing environment, program modules may belocated in both local and remote memory storage devices.

FIG. 11 illustrates various embodiments of a WMD in the form of ageneral-purpose computing device. One of ordinary skill in the art willunderstand, upon reading and comprehending this disclosure, how toimplement the present subject matter using other WMDs and IMDs with someof the illustrated components or other components.

The illustrated computing device 1148 includes a processing unit 1149, asystem memory 1150, and a system bus 1151 that couples the system memoryand other system components to processing unit. The system bus may beany of several types, including a memory bus or memory controller, aperipheral bus, and a local bus, and may use any of a variety of busstructures. The system memory includes read-only memory (ROM) andrandom-access memory (RAM). A basic input/output system (BIOS), storedin ROM, contains the basic routines that transfer information betweencomponents of personal computer. BIOS also contains start-up routinesfor the system. Various embodiments of the computing device furtherinclude a hard disk drive for reading from and writing to a hard disk(not shown), a magnetic disk drive for reading from and writing to aremovable magnetic disk, and an optical disk drive for reading from andwriting to a removable optical disk such as a CD-ROM or other opticalmedium. Hard disk drive, magnetic disk drive, and optical disk drive areconnected to system bus by a hard-disk drive interface, a magnetic-diskdrive interface, and an optical-drive interface, respectively. Thedrives and their associated computer-readable media provide nonvolatilestorage of computer-readable instructions, data structures, programmodules and other data for the computing device. Those skilled in theart will appreciate that other types of computer-readable media whichcan store data accessible by a computer may also be used.

Program modules can be stored on the hard disk, magnetic disk, opticaldisk, ROM and RAM. Program modules may include operating system, one ormore application programs, other program modules, and program data. Auser may enter commands and information into personal computer throughinput devices such as a keyboard and a pointing device. These and otherinput devices are often connected to the processing unit through aserial-port interface coupled to system bus; but they may be connectedthrough other interfaces not shown in FIG. 11, such as a parallel portor a universal serial bus (USB). A monitor or other display device alsoconnects to system bus via an interface such as a video adapter. Inaddition to the monitor, personal computers typically include otherperipheral output devices (not shown) such as speakers and printers. Inone embodiment, one or more speakers or other audio output transducersare driven by sound adapter connected to system bus.

In various embodiments the computing device operates in a networkedenvironment using logical connections to one or more remote devices suchas remote computer. Examples of remote computers include a personalcomputer (PC), a server, a router, a network PC, a peer device, or othercommon network node. In various embodiments, the remote computerincludes many or all of the components described above in connectionwith the computing device; however, only a storage device is illustratedin FIG. 11 to simplify the disclosure. The logical connections depictedin FIG. 11 include local-area network (LAN) and a wide-area network(WAN). Such networking environments exist in offices, enterprise-widecomputer networks, intranets and the Internet. The computing deviceconnects to local network through a network interface or adapter invarious embodiments, and to a WAN/Internet network through a modem orother means for establishing communications over network.

Various embodiments of the present subject matter are illustrated inFIGS. 12-27 and are discussed below. One of ordinary skill in the artwill understand, upon reading and comprehending this disclosure, thatthese embodiments are not necessarily mutually exclusive as variousembodiment can be combined or otherwise modified to create otherembodiments. One of ordinary skill in the art also will understand, uponreading and comprehending this disclosure, that various elements shownand described with respect to one or more of FIGS. 1-11 are capable ofbeing combined with various elements shown and described with respect toone or more of FIGS. 12-27.

Acquisition, Trending and Displaying Health-Related Parameters

FIGS. 12-16 illustrate various embodiments of the present subject matterrelated to acquiring, trending and displaying health-related parameters.In various embodiments, an IMD acquires, trends and displays a varietyof parameters pertinent to the health status of a patient.

FIG. 12 illustrates a block diagram of a device for acquiring, trendingand displaying multiple health-related parameters according to variousembodiments of the present subject matter. The device 1252 acquiresavailable parameters from available sources. In various embodiments, thedevice 1252 includes a WMD such as a portable device, a programmer andthe like. In various embodiments, the device 1252 includes an IMD. Forexample, potentially available sources include an IMD parametercollection 1253 (internal health-related parameters such as internalphysiological measurements, applied therapy, device performance, and thelike), an external parameter collection 1254 (external parameters suchas external physiological and environmental measurements, databases, andthe like), and a user input parameter collection 1255 (voluntary data).User inputs can be considered to be an external health-relatedparameter. However, for purposes of the description with respect to FIG.12, external parameter collection and user input parameter collectionare considered separately.

In various embodiments, the IMD parameter collection 1253 includes atleast one of a physical parameter type, a physiological/pathologicalparameter type, a mental/emotional parameter type, a diet parametertype, an environmental parameter type, a symptom parameter type, and amedical compliance type. In various embodiments, the IMD is gathersinformation from an external device or sensor in order to gather certainparameter types. Furthermore, the IMD is capable of acquiring medicationcompliance by monitoring a measurable parameter correlated tocompliance. For example, blood pressure is monitored to verify that apatient is compliant with hypertensive medications. The IMD is alsocapable of acquiring environmental data, such as barometric pressureusing an implanted pressure sensor and such as relative temperaturechanges using an implanted temperature sensor near the surface of theskin.

One definition of mental is of or relating to the mind. One definitionof emotional is relating to or marked by an emotion (a strong feeling,aroused mental state, or intense state of drive or unrest, which may bedirected toward a definite object and is evidenced in both behavior andin psychologic changes, with accompanying autonomic nervous systemmanifestations). One definition of physiological is normal, as opposedto pathologic. One definition of pathological is diseased. Otherdefinitions can be used consistently with respect to these terms.

In various embodiments, the external parameter collection 1254 includesone or more of a mental/emotional parameter type, an environmentalparameter type and a diet parameter type. In various embodiments, theexternal parameter collection 1254 includes a physical parameter type, aphysiological/pathological parameter type, a symptom parameter type,and/or a medication compliance parameter type. The external parametercollection can include any one or any combination of the above parametertypes according to embodiments of the present subject matter.

In various embodiments, the user input parameter collection 1255includes one or more of a mental/emotional parameter type, anenvironmental parameter type and a diet parameter type. In variousembodiments, the user input parameter collection 1255 includes aphysical parameter type, a physiological/pathological parameter type, asymptom parameter type, and/or a medication compliance parameter type.The user input parameter collection can include any one or anycombination of the above parameter types according to embodiments of thepresent subject matter.

Examples of a physical parameter type include, but are not limited to,parameters related to activity, posture, and sleep. Examples of amental/emotional parameter type include, but are not limited to,parameters related to stress, excitement, anger, anxiety (such as may bedetected via sighing), and depression. Examples ofphysiological/pathological parameter types include, but are not limitedto, parameters related to blood pressure, respiration rate and patterns,and medical test results. Examples of environmental parameter typesinclude, but are not limited to, parameters related to altitude,temperature, air quality, pollen count, and humidity. Examples of dietparameter types include, but are not limited to, parameters related tosodium intake, fluid intake and lipid intake. Examples of symptomparameter types include, but are not limited to, parameters related topain, dyspnea and fatigue. In various embodiments, a symptom can beconsidered to be, for example, a patient-perceived condition based onfrequency, severity and/or repetition. Examples of medication complianceparameter types include, but are not limited to, parameters related todrug administration such as drug type, dosage and time. Examples of drugtype includes insulin, beta-blockers, diuretics and the like.

Health-related parameters are acquired from various sources. In variousembodiments, a number of parameters are acquired from IMD, and fromexternal sources such as external parameter collections (programmer, webservers, patient databases, external sensors, etc.) and user inputparameter collections (answered questions, etc.). The parameter trendsare displayed in a single display area of at least one of the WMDs.

In various embodiments, available parameters are acquired at module1256. The acquired parameters are processed according to a procedureimplemented in software. In various embodiments, the softwareautomatically acquires those health-related parameters deemed to beuseful based on a potential health condition. In various embodiments,the software instructions provide a procedure, when operated on by aprocessor, which automatically determines a potential health condition,and thus additional parameters to be acquired, from previously acquiredparameters. Thus, the present subject matter is capable of automaticallyand intelligently acquiring additional parameters to confirm and/ordismiss an initial diagnosis.

In various embodiments, module 1257 includes software instructions that,when operated on by a processor, provide a procedure that automaticallytrends the acquired parameters. The trending procedure analyzes theparameters as a function of time or other measured parameter. In variousembodiments, module 1258 allows a user to select parameter trends to bedisplayed in a single display area. Module 1259 is used to displayrepresentations in a single display area. In various embodiments inwhich device 1252 includes a WMD, module 1259 displays therepresentation on a display of the WMD. In various embodiments in whichdevice 1259 includes an IMD, module 1259 transmits a signal forreception by a display device to display the representation on thedisplay device.

In various embodiments, the acquired data and trends are analyzed toselect an updated program or specify updated operational parameters forthe IMD. The updated program or operational parameters are capable ofbeing transferred and implemented by IMD.

FIG. 13 illustrates a block diagram of a wellness trending displaygenerally illustrating parameter trends available for display accordingto various embodiments of the present subject matter. In variousembodiments of the display 1360, trends associated with at least one ofa physical parameter type 1361, a physiological/pathological parametertype 1362, a mental/emotional parameter type 1363, an environmentalparameter type 1364, a diet parameter type 1365, a symptom parametertype 1366 and a medication compliance parameter type 1367 (and variouscombinations of a physical parameter type, a physiological/pathologicalparameter type, a mental/emotional parameter type, an environmentalparameter type, a diet parameter type, a symptom parameter type and amedication compliance parameter type) are available to be displayed in asingle wellness trending display area 1360.

In various embodiments, parameters available to be displayed that areassociated with a physical parameter type include, but are not limitedto, parameters related to activity, posture, and sleep. In variousembodiments, parameters available to be displayed that are associatedwith a mental/emotional parameter type include, but are not limited to,parameters related to stress, anxiety (such as may be detected viasighing), excitement, anger and depression. In various embodiments,parameters available to be displayed that are associated with aphysiological/pathological parameter type include, but are not limitedto, parameters related to blood pressure, respiration rate and patterns,and medical test results. In various embodiments, parameters availableto be displayed that are associated with a environmental parameter typeinclude, but are not limited to, parameters related to altitude,temperature, air quality, pollen count and humidity. In variousembodiments, parameters available to be displayed that are associatedwith a diet parameter type include, but are not limited to, parametersrelated to sodium intake, fluid intake and lipid intake.

FIG. 14 illustrates a block diagram of a wellness trending displayillustrating an arrangement for selecting and displaying parametertrends according to various embodiments of the present subject matter.In the illustrated embodiment, the screen display 1460 of the WMDincludes a patient health trend area 1468A, a device trend area 1468B,and a trend display area 1468C. In various embodiments, the screendisplay includes a time indicator 1469 and an event identifier 1470. Theevent identifier is used to display predetermined events. In variousembodiments, significant events include events that are clinicallyimportant in themselves, those events that may trigger clinicallyimportant changes, and/or those events that explain clinically importantchanges. The illustrated screen display promotes the correlation ofvarious parameter trends to various predetermined events. Thecorrelation of various parameter trends is useful to diagnose and treatvarious health conditions.

In various embodiments, various trended parameters from the patienthealth trend area and from the device trend area are capable of beingdisplayed in the trend display area. In various embodiments, a user iscapable of selecting the displayed parameters and/or is capable ofmodifying the scale, arrangement and/or other display characteristic.

The illustrated patient health trend area 1468A includes a physicalparameter type 1461, a physiological/pathological parameter type 1462, amental/emotional parameter type 1463, an environmental parameter type1464, a diet parameter type 1465, a symptom parameter type 1466 and amedication condition parameter type 1467. In various embodiments,selecting the parameter type displays a second window for selecting aparticular parameter associated with that parameter type. For example,selecting the physical parameter type button displays available physicalparameters for display such as activity, posture and sleep. Otherembodiments provide other ways for a user to select the parameters to bedisplayed.

The illustrated device trend area 1468C includes parameters associatedwith the device that can affect the sensed parameters or that otherwiseprovide context to the sensed parameters. In various embodiments of thepresent subject matter which include a pulse generator IMD, the devicetrend area includes battery impedance 1471, lead impedance 1472, andpercent pacing 1473. One of ordinary skill in the art will understand,upon reading and comprehending this disclosure, the significance ofdevice trends such as battery impedance, lead impedance, percent pacingand the like. One of ordinary skill in the art will further understand,upon reading and comprehending this disclosure, the desirability ofcorrelating device trends with the patient health trends.

A number of parameters trends, shown as trend 1, trend 2 . . . trend n,are capable of being displayed in the trend display area 1468B. Thetrends are plotted as a function of time, which is illustrated at 1469.In various embodiments, and event identifier, represented at 1470, isalso displayed in the trend display area. The event identifier displayspredetermined events that occurred at various times, and assists withdetermining causes for changes in the displayed parameter trends.

FIG. 15 illustrates an example of a wellness trending display. In theillustrated embodiment, the screen display of the wellness monitordevice includes a patient health trend area 1566, a device trend area1568, and a trend display area 1567.

In the illustrated embodiment, a number of patient health parametertrends are accessible in the patient health trend area, including meanresting heart rate trends, an activity trends, standard deviation ofaveraged normal-to-normal (SDANN) interval trends, percent atrialfibrillation (AF) trends, intrinsic PR interval trends (the period oftime from the onset of the P wave (atrial depolarization) to the onsetof the QRS complex (ventricular depolarization)), autonomic balancetrends, and mean resting respiratory trends.

SDANN is a particular measure of heart rate variability (HRV) that isbased on 24 hour recordings of heartbeats. SDANN is computed bydetermining average heart rate over a given interval (e.g. five (5)minute intervals), and taking the standard deviation of the heart rates.Preferably, the SDANN measure uses every interval during the dayassuming that all of the intervals provide good recordings. For example,there are 288 5-minute periods during a day. If all of the intervalsprovide good recordings, the SDANN is the standard deviation of these288 averages. However, since all of the recordings may not be goodthroughout the 24 hour day, the SDANN is computed from the good portionsof the recording.

Upon reading and understanding this disclosure, those skilled in the artwill readily understand the value of the heart rate, percent atrialfibrillation, autonomic balance, and respiratory trends in the contextof patient wellness. The intrinsic PR interval is useful to determineoptimal cardiac resynchronization therapy in heart failure patients.

In the illustrated embodiment, a number of device trends 1568 areaccessible in the device trend area, including percent ventricularpacing trends, atrial lead impedance trends, RV lead impedance trends,LV lead impedance trends, atrial intrinsic amplitude trends, rightventricular amplitude trends, and left ventricular amplitude trends.Upon reading and comprehending this disclosure, those skilled in the artwill readily understand the value of the parameters in assessing devicefunctionality and thereby the ability of the device to deliver propertherapy.

Labels are provided in FIG. 15 to illustrate the correlation betweenvarious parameter trends and various predetermined events. For example,programming the IMD, as indicated by the event identifier, resulted in alower resting mean heart rate and an increased activity. U.S. Pat. No.6,021,351, issued to Kadhiresan et al. and entitled Method and ApparatusFor Assessing Patient Well-Being, describes an example of an activity.U.S. Pat. No. 6,021,351 is assigned to Applicant's assignee, and ishereby incorporated by reference in its entirety. The illustration alsoshows that a ventricular tachycardia (VT) shock therapy did notsignificantly affect the heart rate or activity, but that atrialfibrillation (AF>15%) significantly worsened the patient's health statusas indicated by an increased resting mean heart rate and a decreasedactivity. One of ordinary skill in the art will understand, upon readingand comprehending this disclosure, that other parameters andpredetermined events can be acquired and displayed to illustrate thecorrelation between various parameter trends and various predeterminedevents.

FIG. 16 illustrates a block diagram according to various aspects of thepresent subject matter in which a diagnostic context is provided toassist with interpreting the health condition of the patient, and toappropriately adjust the device and/or medical therapy, accordingly. Thepatient diagnostics 1669 and the diagnostic context 1670 are capable ofbeing acquired using a variety of IMD and external sources, such asthose provided throughout this disclosure. A number of patientdiagnostics and diagnostic contexts are provided in FIG. 15, and willnot be repeated in this specification.

In the illustrated embodiment, the diagnostic context 1670 is used as aninput in forming the patient diagnosis 1669. The diagnostic context andthe patient diagnostics provide inputs to titration algorithms 1671,which are used to determine an appropriate device therapy based on thediagnosis and the context of the diagnosis. The titrated settings forthe device therapy are implemented by the device at 1672. At 1673,various trends, reports and/or alerts/alarms are determined based on thepatient diagnostics. A physician 1674 receives these various trends,reports and/or alerts/alarms, along with other data 1675 such asclinical exams, clinical data, medical history and the like. Based onthe available information, the physician is able to adjust (or titrate)the device therapy 1672 and/or the medical therapy 1676.

Defining, Identifying and Using Predetermined Health-Related Events

FIGS. 17-19 illustrate various embodiments of the present subject matterrelated to defining, identifying and using predetermined health-relatedevents. In various embodiments, a device such as a WMD or IMD defines,identifies, displays and triggers actions based on a predeterminedhealth-related event. In various embodiments, the predetermined eventsinclude significant events that are clinically important. Significantevents includes those events that are clinically important in themselves(such as ventricular fibrillation), those events that trigger animportant change (such as loss of ventricular pacing) or those eventsthat explain a change (such as increased anxiety).

FIG. 17 illustrates a method for managing a patient's health bydefining, detecting and using predetermined health-related events,according to various embodiments of the present subject matter. At 1777,predetermined events are defined. In various embodiments, predeterminedevents are significant health-related events, such as events that areclinically important in themselves, events that trigger a change, and/orevents that explain a change. Examples of predetermined events includesdevice (e.g. IMD) therapy changes initiated by the device and/orclinician, a drug therapy change initiated by the device and/orclinician, arrhythmic events, changes in trended parameters, andautonomously-identified parameter correlations.

At 1778, predetermined health-related events are detected based onhealth-related parameters. In various embodiments, the health-relatedparameters are acquire through IMD sensors, external sensors, externaldata sources such as patient databases, and/or manual data inputs. At1779, the detected event is recorded in a time log. In variousembodiments, a time stamp is associated with the event to record thetime to of the event.

At 1780, an action is triggered based on the detected events. In variousembodiments, the triggered action includes a change in device therapy,an alarm and/or a display or report of the predetermined events alongwith trended health-related parameters. In various embodiments, thetriggered action includes initiating a signal for use within thedevice(s) that detected the events for transmission for use by otherdevice(s).

FIG. 18 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of detecting predeterminedhealth-related events, according to various embodiments of the presentsubject matter. The illustrated device includes a parameter acquisitionmodule 1881 to acquire health related parameters. These health-relatedparameters can include IMD parameters (whether sensed or deviceinterrogated), and parameters from external data sources such as sensorsand databases. Various embodiments acquire various health-relatedparameters that are provided throughout this disclosure. The illustrateddevice 1852 further includes a predetermined event detection module incommunication with the parameter acquisition module. The predeterminedevent detection module 1882 communicates with the parameter acquisitionmodule 1881 to determine whether the health-related parameter(s)correspond to at least one of the number of predetermined events. Theillustrated device further includes an action trigger module 1883 tocommunicate with the predetermined event detection module and trigger atleast one action appropriate for a detected predetermined event.

FIG. 19 illustrates a wellness monitoring device (WMD) for monitoring apatient's health condition that is capable of detecting predeterminedhealth-related events, according to various embodiments of the presentsubject matter. The illustrated device 1952 includes a communicationmodule 1984, a parameter acquisition module 1981, an input module 1985,a predetermined event definition module 1986, a timer module 1987 and apredetermined event detection module 1982. In operation, the modulesperform the functions as described below.

The communication module 1984 receives at least one health-relatedparameter. The parameter acquisition module 1981 communicates with thecommunication module to acquire the at least one health-relatedparameter. The input module 1985 receives manual input data, such asdata for defining predetermined events and/or parameters to be acquiredby the parameter acquisition module 1981 through a communication link.The predetermined event definition module 1986 communicates with theinput module 1985 and/or a memory storage that contains a set ofpredetermined health-related events 1988 to define a number ofpredetermined events for the patient's health condition. Thepredetermined event detection module 1982 communicates with theparameter acquisition module 1981 and the predetermined event definitionmodule 1986 to determine that the health-related parameter(s) correspondto at least one of the number of predetermined events. The predeterminedevent detection module 1982 further communicates with the timer module1987 to associate a time with the at least one of the number ofpredetermined events.

Various embodiments of the present subject matter include an actiontrigger module 1983 in communication with the predetermined eventdetection module. The action trigger module 1983 is adapted to trigger adesired action based on a detected predetermined event. In variousembodiments, the action trigger is adapted to provide a signal todisplay the detected predetermined event along with a trend for the atleast one health related parameter. In various embodiments, the deviceincludes a display on which the predetermined event and the trend forthe at least one health related parameter are displayed. In variousembodiments, the signal is transmitted to another device with a displayon which the predetermined event and the trend for the at least onehealth related parameter are displayed. In various embodiments, theaction trigger is adapted to provide a signal to send an alarm inresponse to the detected predetermined event. Various embodiments of thepresent subject matter include an action trigger to provide a signal tochange device therapy in response to the detected predetermined event.

The health-related parameters acquired by the parameter acquisitionmodule 1981 are capable of including IMD parameters or health-relatedparameters from an external data source such as external sensors,patient history databases, databases accessible through a globalcomputer network (e.g. Internet), and user inputs (e.g. manual inputsfrom a patient and/or clinician).

Reporting Multiple Health-Related Parameters

FIGS. 20-21 illustrate various embodiments of the present subject matterrelated to reporting multiple health-related parameters. Variousembodiments of the present subject matter provide a number of methodsfor transferring trended data, predetermined events and alerts to aclinician. In various embodiments, this type of information is capableof being displayed on a programmer screen or being otherwise used by aWMD and/or IMD within an advanced patient management system, such asthose described within this disclosure, for example. This information isfiltered in various embodiments of the present subject matter such thatonly the most relevant or clinically useful information is displayed orotherwise used.

FIG. 20 illustrates a method for reporting multiple parameters relatedto a health condition of a patient, according to various embodiments ofthe present subject matter. At 2088, a number of trended health-relatedparameters are acquired. In various embodiments, the trendedhealth-related parameters include any of the various parametersdescribed within this disclosure. In various embodiments, acquiring thetrended health-related parameters includes acquiring parameters andtrending the acquired parameters. At 2089, a number of predeterminedevents are acquired. In various embodiments, the predetermined eventsinclude events that are clinically important in themselves, events thattrigger a change, or events that explain a change. In variousembodiments, acquiring predetermined events include determining that theevent is a significant health-related event as provided elsewhere inthis disclosure. At 2090, a number of alerts are acquired. In variousembodiments, acquiring alerts includes determining alerts. Alerts invarious embodiments of the present subject matter includedevice-initiated alerts, patient-initiated alerts, andclinician-initiated alerts. Additionally, alerts in various embodimentsof the present subject matter include alerts directed to the patient andalerts directed to a clinician.

At 2091, the present subject communicates at least one of theparameters, events and/or alerts. Various embodiments prioritize orcharacterize the relevance of the parameters, events and/or alerts, andappropriately communicate the information according to the relevance ofthe information. In various embodiments, the parameters, events and/oralerts are communicated in a report-like manner. Various embodiments ofthe present subject matter communicate the parameters, events and/oralerts incorporating a variety of communication technologies provided inthis disclosure. In various embodiments, the communication displayingthe parameters, events and/or alerts, providing an alarm signal withrespect to the parameters, events and/or alerts, transmitting an e-mail,transmitting a telefax, placing a telephone call, and conductingwireless communication.

FIG. 21 illustrates a wellness monitoring device (WMD) for monitoring apatient's health condition that is capable of prioritizing communicationof health-related parameters, according to various embodiments of thepresent subject matter. The illustrated device 2152 includes acommunication module 2184, a parameter acquisition module 2181, an inputmodule 2185, a predetermined event definition module 2186, a timermodule 2187, a predetermined event detection/acquisition module 2182,and an alert acquisition module 2192. In operation, the modules performthe following functions. The communication module 2184 receives at leastone health-related parameter. The parameter acquisition module 2181communicates with the communication module 2184 to acquire the at leastone health-related parameter. The input module 2185 receives manualinput data, such as data for defining predetermined events and/orparameters acquired by the parameter acquisition module 2181 through acommunication link. The predetermined event definition module 2186communicates with the input module 2185 to define a number ofpredetermined events for the patient's health condition. Thepredetermined event detection/acquisition module 2182 communicates withthe parameter acquisition module 2181 and the predetermined eventdefinition module 2186 to determine that the health-related parameter(s)correspond to at least one of the number of predetermined events. Thepredetermined event acquisition module 2182 further communicates withthe timer module 2187 to associate a time with the at least one of thenumber of predetermined events. The alert acquisition module 2192communicates with the predetermined event acquisition module 2182 andwith an alert definition module 2193 to determine alerts from, amongother things, the acquired predetermined events.

Various embodiments of the present subject matter include an outputcommunication module 2194 in communication with the alert acquisitionmodule 2192, the predetermined event acquisition module 2182 and theparameter acquisition module 2181. In various embodiments, the outputcommunication module 2194 is in communication with a priority filter2195 for characterizing or classifying the relevance of theparameter(s), event(s) and/or alert(s). The output communication module2194 is adapted to appropriately communicate the parameter(s), event(s)and/or alert(s) using various communication technologies based on theirrelevance.

One of ordinary skill in the art will understand, upon reading andcomprehending this disclosure, how to acquired parameters, events and/oralerts using an IMD, and transmitting a communication signal representedthe acquired parameters, events and/or alerts from the IMD to assistwith managing a patient's health.

Environmental Data

FIG. 22 illustrates various embodiments of the present subject matterrelated to reporting environmental data. Various embodiments of thepresent subject matter automatically acquire and present environmentaldata to the attending physicians and/or patients for disease diagnosisand therapy decision making. For example, chronically ill patients canbe very sensitive to the environment changes such as air quality andtemperature. Patients who have respiratory disorders secondary tocardiovascular diseases (e.g. HF) may be vulnerable to certainenvironmental conditions. For example, acute exacerbation sometimes canbe attributed to environmental changes. In various embodiments, a device(such as an IMD and/or WMD) is able to automatically acquireenvironmental data and provide such information in correlation to othermeasurements of the patient conditions to the clinician and/or patient.

FIG. 22 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of synthesizing environmentalparameters with implantable medical device (IMD) parameters, accordingto various embodiments of the present subject matter. Examples ofenvironmental parameter types include, but are not limited to,parameters related to altitude, temperature, air quality, pollen count,and humidity. The illustrated device 2252 includes a first communicationmodule 2296 for receiving IMD parameters, and a second communicationmodule 2297 for receiving environmental parameters from a source ofenvironmental parameters (such as an external sensor or a database). Thedevice includes a correlation module 2298 that receives the IMDparameter(s) and the environmental parameter(s), and correlates theenvironmental parameters with the IMD parameters.

Various embodiments of the present subject matter include an actiontrigger module 2283 in communication with the correlation module 2298.The action trigger module 2283 is adapted to trigger a desired actionbased on the IMD parameter(s) and the environmental parameter(s). Invarious embodiments, the action trigger module 2283 is adapted toprovide a signal to display the correlation between the IMD parameter(s)and the environmental parameter(s).

In various embodiments, the device 2252 includes a display on which thecorrelation between the IMD parameter(s) and the environmentalparameter(s) is displayed. In various embodiments, the signal istransmitted to another device with a display on which the correlationbetween the IMD parameter(s) and the environmental parameter(s) isdisplayed. In various embodiments, the action trigger is adapted toprovide a signal to send an alarm in response to the correlation betweenthe IMD parameter(s) and the environmental parameter(s). Variousembodiments of the present subject matter include an action triggermodule 2283 to provide a signal to change device therapy in response tothe correlation between the IMD parameter(s) and the environmentalparameter(s).

In various embodiments, the device 2252 further includes a thirdcommunication module 2299 to receive IMD position parameters. Thus, forexample, in an embodiment in which the second communication module isaccessing environmental parameter(s) from a database of regionalenvironmental parameters, the present subject matter is capable ofdetermining the appropriate region for which to retrieve environmentalparameters. Additionally, in various embodiments, the IMD positionparameters include parameters indicative of altitude. According tovarious embodiments, the IMD position parameters are generated usingcellular technology to determine a cell region, GPS technology, andmanual data inputs.

Various embodiments of the present subject matter relate to an advancedpatient management system. In various embodiments, the system includesat least one implantable medical device (IMD) to acquire at least oneIMD parameter indicative of patient wellness, means to acquire at leastone environmental parameter from at least one external source, and meansto factor in the at least one environmental parameter in the advancedpatient management system. In various embodiments, the environmentalparameter is factored in by adjusting the IMD parameter based on the atleast one environmental parameter. In various embodiments, theenvironmental parameter is factored in by adjusting a display of the IMDparameter. In various embodiments, the environmental parameter isfactored in by adjusting IMD-provided therapy (such as electricaltherapy, drug therapy, and the like). A number of environmentalparameter types are acquired in various embodiments. Examples of theseenvironmental types include altitude, temperature, air quality, pollencounts, humidity, and pressure. In various embodiments, the IMDparameter(s) and/or the environmental parameter(s) are trended and/orcorrelated, as provided in this disclosure.

Identifying, Displaying and Assisting in Correlating Health-Related Data

FIG. 23 illustrates various embodiments of the present subject matterrelated to identifying, displaying and assisting in data correlation.One definition of correlation is a relation existing between phenomenaor things or between mathematical or statistical variables which tend tovary, be associated, or occur together in a way not expected on thebasis of chance alone. Correlating data involves showing a reciprocal,mutual, and/or causal relationship among the data.

Various embodiments of the present subject matter provide methods ofcorrelating, or assisting in the correlation of, trended data,predetermined events and other actions taken by the system (such as analert transmitted to the clinician). Various embodiments of the presentsubject matter autonomously identify correlations and display theidentified correlations. For example, various embodiments determinecorrelations without human intervention. In various embodiments, thepresent subject matter assists the clinician in correlating theinformation by displaying the data in an appropriate manner. Cause andeffect relationships that are suitable for use in treating patients canbe established by correlating data items.

FIG. 23 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of correlating trendedparameters, predetermined events, and alerts, according to variousembodiments of the present subject matter. The illustrated device 2352includes a first data input 2301 to receive trended health-relatedparameter(s), a second data input 2302 to receive predetermined event(s)associated with a patient's health, and a third data input 2303 toreceive alert(s) associated with a patient's health. According tovarious embodiments of the present subject matter, the health-relatedparameters, the predetermined events, and the alerts include any of thehealth-related parameters, the predetermined events, and the alertsprovided throughout this disclosure.

The device 2352 includes a correlation module 2304 in communication withthe first data input 2301, the second data input 2302, and the thirddata input 2303. The correlation module 2304, which in uses variouscorrelation algorithms 2305 in various embodiments, is adapted tocorrelate at least one of one or more trended health-related parameters,one or more health-related predetermined events, and one or morehealth-related alerts. In various embodiments, the correlation module2304 is adapted to trigger an action. In various embodiments, the actionis automatically triggered based on the correlation. In variousembodiments, the correlation module automatically triggers an IMDtherapy change based on the correlation. In various embodiments, thecorrelation module automatically displays the correlation. For example,a cursor or other indicator can be used to highlight the correlation.

Those versed in the art will understand, upon reading and comprehendingthis disclosure, how to incorporate various well known techniques forcomputing correlations between two or more data sources. For example, inthe case of providing correlations between two data sources, Pearson'sproduct-moment correlations is one example of a type of correlation thatmay be computed. In the case of three or more data sources, multivariatecorrelation techniques may be employed.

According to various embodiments of the present subject matter, thechoice of which data sources to correlate is based on knowledge ofphysiological coupling between the sources. According to variousembodiments, the choice of which data sets to correlate and the timedurations(s) over which the correlations are computed is determined atthe start of monitoring, and is either the same for each patient, or istailored to individual patients based on the physicians' knowledge ofthe patient's condition. In various embodiments, the decisions of whichparameters to correlate with each other may be dynamically selectedbased on ongoing IMD or WMD monitoring of the patient's physiology.

Composite Parameter Indices

FIGS. 24-26 illustrate various embodiments of the present subject matterrelated to defining, identifying and utilizing composite parameterindices. A composite parameter is a parameter created by combining twoor more parameter inputs. For example an exercise conditioning compositeparameter is generated by dividing a heart rate by an activity level. Alower exercise condition composite parameter indicates that a patient isin better condition. Various embodiments of the present subject matterprovide composite parameters that function as trended parameters invarious manner in which the trended parameters are used, as providedthroughout this disclosure. A composite parameter is capable of beingused in any way a raw parameter is used, such as displaying,correlating, defining predetermined events, defining alerts, and thelike.

FIG. 24 illustrates a method to generate composite parameters for use inmanaging a patient's health, according to various embodiments of thepresent subject matter. The method illustrates a first parameter 2406and a second parameter 2407 being operated on to form a compositeparameter 2408. One or ordinary skill in the art will understand, uponreading and comprehending this disclosure, that the operation denoted at2409 can be any number of mathematical and/or logical operations. Forexample, the composite parameter 2408 can be formed by multiplying thefirst parameter 2406 and the second parameter 2407, or can be formed bydividing the second parameter 2407 into the first parameter 2406. Morecomplex mathematical and/or logical operations can be used to generatethe composite index.

FIG. 25 illustrates a method to generate composite parameters for use inmanaging a patient's health, according to various embodiments of thepresent subject matter. The method illustrates a number of parameters(1, 2, P) and a number of composite parameters (1, 2, C) that arecapable of being combined to form one or more composite parameters 2508.Thus, the present subject matter is capable of generating a compositeparameter from any number of health-related parameters, from any numberof previously-determined composite parameters, or from any combinationof one or more parameters and one or more composite parameters.

In various embodiments, the parameters include IMD-measured parametersand/or IMD-interrogated parameters. IMD-interrogated parameters include,for example, parameters related to a device status such as battery orlead impedance. In various embodiments, the parameters includeuser-inputted parameters provided by a patient, clinician or otherperson.

Various embodiments of the present subject matter combine two or morehealth-related parameters related to a body system to generate acomposite parameter that is indicative of the health of the body system.For example, respiratory rate, tidal volume, maximum oxygen consumption(VO2) and periodic breathing parameters relate to a respiratory system.These parameters can be used to generate a single composite parameterindex that provides a health indication concerning the respiratorysystem. Another example uses an average heart rate and an activityparameter to generate a composite parameter index indicative of physicalconditioning. Other examples use cardiac output and vascular pressuresto measure vascular resistance. Another example measures respiration andheart rate to measure respiratory sinus arrhythmia.

In various embodiments, the composite index is displayed with trendedhealth-related parameter(s), predetermined event(s) and/or alert(s). Invarious embodiments, the composite parameter is used to define apredetermined health-related event. In various embodiments, thecomposite parameter is used to define a clinician alert. In variousembodiments, the composite parameter is used to modify device therapy.

FIG. 26 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of generating compositeparameters, according to various embodiments of the present invention.The illustrated device 2652 includes a data input 2610 to receive two ormore health-related parameters and a composite generating module 2611 incommunication with the data input 2610. In operation, the compositegenerating module 2611 receives the health-related parameters andgenerates a composite parameter using the health-related parameters. Thecomposite generating module 2611 is capable of performing any number ofmathematical and/or logical operations, such as that denoted at 2409 inFIG. 24. In various embodiments, the composite generating module 2611 iscapable of combining one or more composite parameters (represented byline 2612) with one or more health-related parameters to form othercomposite parameters.

Various embodiments provide various composite parameters. A number ofthese composite parameters are identified below. The identifiedcomposite parameters is not intended to be an exclusive list of theavailable composite parameters.

In a first example, a composite parameter indicative of systemicvascular resistance (SVR) is generated using an acquired cardiac outputparameter (C.O.), a mean arterial pressure parameter (/P_(ART)), and amean right atrial pressure parameter (/P_(RA)). In various embodiments,the SVR composite parameter is provided by:

${S\; V\; R} = {\frac{\overset{\_}{P_{ART}} - \overset{\_}{P_{RA}}}{C.O.}.}$

In a second example, a composite parameter indicative of pulmonaryvascular resistance (PVR) is generated using an acquired cardiac outputparameter (C.O.), a mean pulmonary artery pressure parameter (/P_(PA)),and one of a mean pulmonary capillary wedge pressure parameter (/P_(CW))and a mean left atrial pressure parameter (/P_(LA)). In variousembodiments, the PVR composite parameter is provided by:

${{P\; V\; R} = \frac{\overset{\_}{P_{PA}} - \overset{\_}{P_{CW}}}{C.O.}},{{{or}\mspace{14mu} P\; V\; R} = {\frac{\overset{\_}{P_{PA}} - \overset{\_}{P_{LA}}}{C.O.}.}}$

In a third example, a composite parameter indicative of respiratorysinus arrhythmia (RSA) is generated using an acquired heart rateparameter (P_(HR)) and a parameter related to instantaneous lung volume(P_(LV)). For example, a trans-thoracic sensor can be used in theacquisition. In various embodiments, the RSA composite parameter isprovided by:RSA=f(P _(HR) ,P _(LV)).

In a fourth example, a composite parameter indicative of a degree ofdyspnea (D) is generated using an acquired respiration rate parameter(P_(RR)) and a tidal volume parameter (P_(TV)). In various embodiments,the dyspnea composite parameter is provided by:

$D = {\frac{P_{RR}}{P_{TV}}.}$

Context may temporarily affect the physiological condition of amonitored patient. A patient context (or body-related concept), forexample, may include posture, activity level, mental/emotional state andthe like. Examples of patient contexts include sleeping or lying down,running, and driving. An environmental context (or external factor), forexample, may include ambient temperature, sound level and the like. Theconcept of context has previously been discussed with respect to FIG.16.

In various embodiments, the context is correlated with the physiologicmeasurements. In various embodiments, measurements are taken only forcertain contexts so as to provide a repeatable baseline. For example, itis preferred to measure some parameters when a patient is at rest or ina known position. Thus, repeatable composite parameters can begenerated. This is useful to determine trends or deviations from normalvalues. Additionally, various embodiments determine the context toprovide an appropriate therapy for a contextual situation.

The following commonly-assigned patent applications refer to the use ofmultiple parameters and are herein incorporated by reference in theirentirety: “Implantable Cardiac Rhythm Management Device For AssessingStatus of CHF Patients,” Ser. No. 09/434,009, filed Nov. 4, 1999, nowU.S. Pat. No. 6,275,727; “Method and Apparatus For Determining ChangesIn Heart Failure Status,” Ser. No. 10/001,223, filed Nov. 15, 2001, nowU.S. Pat. No. 6,980,851; and “Cardiac Rhythm Management Systems andMethods Predicting Congestive Heart Failure Status,” Ser. No.10/213,268, filed Aug. 6, 2002, now U.S. Pat. No. 7,127,290. Thefollowing commonly-assigned patent application refers to context and isherein incorporated by reference in its entirety: “Methods and DevicesFor Detection of Context When Addressing A Medical Condition of aPatient”, Ser. No. 10/269,611, filed Oct. 11, 2002, now U.S. Pat. No.7,400,928.

Cardiac failure refers to a condition in which the heart fails to pumpenough blood to satisfy the needs of the body. It is usually due to somedamage to the heart itself, such as from a myocardial infarction orheart attack. When heart failure occurs acutely, autonomic circulatoryreflexes are activated that both increase the contractility of the heartand constrict the vasculature as the body tries to defend against thedrop in blood pressure. Venous constriction, along with the reduction inthe heart's ability to pump blood out of the venous and pulmonarysystems (so-called backward failure), causes an increase in thediastolic filling pressure of the ventricles. This increase in preload(i.e., the degree to which the ventricles are stretched by the volume ofblood in the ventricles at the end of diastole) causes an increase instroke volume during systole, a phenomena known as the Frank-Starlingprinciple. If the heart failure is not too severe, this compensation isenough to sustain the patient at a reduced activity level. When moderateheart failure persists, other compensatory mechanisms come into playthat characterize the chronic stage of heart failure. The most importantof these is the depressing effect of a low cardiac output on renalfunction. The increased fluid retention by the kidneys then results inan increased blood volume and further increased venous return to theheart. A state of compensated heart failure results when the factorsthat cause increased diastolic filling pressure are able to maintaincardiac output at a normal level even while the pumping ability of theheart is compromised.

Compensated heart failure, however, is a precarious state. If cardiacfunction worsens or increased cardiac output is required due toincreased activity or illness, the compensation may not be able tomaintain cardiac output at a level sufficient to maintain normal renalfunction. Fluid then continues to be retained, causing the progressiveperipheral and pulmonary edema that characterizes overt congestive heartfailure. Diastolic filling pressure becomes further elevated whichcauses the heart to become so dilated and edematous that its pumpingfunction deteriorates even more. This condition, in which the heartfailure continues to worsen, is decompensated heart failure. It can bedetected clinically, principally from the resulting pulmonary congestionand dyspnea, and all clinicians know that it can lead to rapid deathunless appropriate therapy is instituted.

Resynchronization pacing is effective in treating heart failure becausepump function is improved when the ventricles are caused to contract ina more coordinated manner. Heart failure can also be treated medicallywith diuretics to decrease fluid retention, vasodilators to decreasepreload and afterload, and ionotropic agents to increase myocardialcontractility. All of these treatment modalities need to be optimizedfor the individual patient, and therapy adjustments need to be made whena patient's heart failure status changes if the progressive heartfailure described above is to be avoided.

Studies have shown that patients with chronic heart failure are limitedby exertional dyspnea and exercise intolerance. Such patients oftenexhibit elevated ventilatory response to exercise, which can becharacterized by a steeper slope relating minute ventilation to carbondioxide output during exercise. In addition to the increasedventilation, such patients have also been noted to have an abnormalbreathing pattern, such that at a given minute ventilation, respiratoryrate is increased while the change in tidal volume is less significantcompared with normal subjects. The ventilatory response to exercise, ascharacterized by the regression slope relating minute ventilation tocarbon dioxide output during exercise by CHF patients, has been found tobe significantly higher in such patients than for normal subjects.

The status of heart failure can be detected from the resulting pulmonarycongestion and dyspnea. Transthoracic impedance can provide an estimateof minute ventilation, respiratory rate and tidal volume, and can beused to provide congestive heart failure status.

Triaging Health-Related Data

FIGS. 27-28 illustrates various embodiments of the present subjectmatter related to triaging health-related data in an advanced patientmanagement system. Various embodiments of the present subject matterprovide one or more devices (such as IMD, WMD, programmer and the like)with the ability to rank the severity of predetermined events. Thisranking is used to prioritize the processing of the predetermined eventsand respond in an appropriate manner. For example, the system can bedesigned such that a modest increase in heart rate holds a lowerpriority and is related to the clinician at a next patient followup;whereas a sudden increases in weight (which may be associated with acutedecompensation in a heart failure patient) may be assigned a higherpriority and immediately be communicated to the clinician throughvarious communication means.

FIG. 27 illustrates a method to triage predetermined events for use inmanaging a patient's health, according to various embodiments of thepresent subject matter. At 2713, predetermined events are acquired. At2714, the acquired predetermined events are classified, ranked, sortedor filtered according to severity. At 2715, an action is triggered basedon the severity of the predetermined event. According to variousembodiments, the action includes one or more of displaying thepredetermined event to a clinician at a patient followup visit 2716,alerting a clinician of the predetermined event at a patient followupvisit 2717, initiating an alert for the patient 2718, altering devicetherapy 2719, and initiating an alert (such as a prompt emergency alert)to the clinician using an advance patient management system 2720. Invarious embodiments, the above-identified actions are performed forpredetermined events that have been classified for increasing severitysuch that action 2716 is performed for a less severe event than action2717, which is performed for a less severe event than action 2718, whichis performed for a less severe event than action 2719, which isperformed for a less severe event than action 2710. Other actions can beperformed according to the severity of the predetermined event.

In various embodiments, the available actions to be performed areassociated with various severity levels for predetermined events. Thisinformation is stored in a computer-readable memory such that a deviceis capable of performing an action that is associated with a detectedpredetermined event.

FIG. 28 illustrates a device (such as a WMD or IMD) for monitoring apatient's health condition that is capable of classifying a number ofpredetermined events according to severity, and performing a systemaction based on the classification, according to various embodiments ofthe present subject matter. The illustrated device 2852 includes aninput module 2821 and a triage module 2822.

In various embodiments, the input module 2821 acquires predeterminedevents. In various embodiments, the input module 2821 includes apredetermined event determination module 2823 to determine whether apredetermined event has occurred. In various embodiments, the inputmodule 2821 includes a first communication module 2824 to acquire IMDparameters for use by the predetermined event determination module 2823.In various embodiments, the input module 2821 includes a secondcommunication module 2825 to acquire database parameters for use by thepredetermined event determination module.

The triage module 2822 receives the predetermined event(s) and ranks orotherwise classifies, the predetermined events according to severity. Invarious embodiments, the device 2852 includes a triggering module 2826in communication with the triage module 2822. The triage module 2822 isadapted to automatically initiate a desired action by the triggeringmodule 2826 based on the severity of the predetermined event. In variousembodiments, the action initiated is appropriate for the severity of theevent. In various embodiments, a communication or report is initiated bythe device when a predetermined event is classified as being moresevere. For example, the communication can be an alarm or a prominentlydisplayed message. In various embodiments, a communication or report isprovided during a subsequent patient follow-up session when apredetermined event is classified as being less severe. In variousembodiments, the device 2852 automatically performs a desired systemaction selected from a number of available system actions. The action isselected based on the severity of the predetermined event.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement which is calculated to achieve the same purpose maybe substituted for the specific embodiments shown. This application isintended to cover any adaptations or variations of the present subjectmatter. It is to be understood that the above description is intended tobe illustrative, and not restrictive. Combinations of the aboveembodiments, and other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the presentsubject matter should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

What is claimed is:
 1. A system for monitoring a heart failure status ofa heart failure patient, comprising: an implantable medical device; anda programmable device having machine executable instructions forperforming a method to assist with managing a patient's health, themethod performed by the programmable device including acquiring from theimplantable medical device sensed physiological parameters, and usingthe sensed physiological parameters to generate a composite parameterindicative of respiratory sinus arrhythmia (RSA), wherein the sensedparameters acquired from the implantable medical device includes sensedheart rate and sensed respiration, and using the sensed physiologicalparameters to generate the composite parameter indicative of RSAincludes using a function of the sensed heart rate and the sensedrespiration to generate the composite parameter indicative of RSA. 2.The system of claim 1, further comprising a trending module configuredto trend the composite parameter and one or more of the sensedphysiological parameters sensed by the implantable medical device. 3.The system of claim 2, wherein the system includes a display and themethod performed by the programmable device includes displaying one ormore trends of the composite parameter on the display.
 4. The system ofclaim 2, wherein the method performed by the programmable deviceincludes acquiring a patient context or environmental context, whereinthe trending module is configured to trend the patient context orenvironmental context with the composite parameter.
 5. The system ofclaim 4, wherein, in the method performed by the programmable device,acquiring the patient context or environmental context includesacquiring a patient context selected from the group of patient contextsconsisting of posture, activity level, sleep/wake state, andmental/emotional state.
 6. The system of claim 4, wherein, in the methodperformed by the programmable device, acquiring the patient context orenvironmental context includes acquiring an environmental contextselected from the group of environmental contexts consisting oftemperature, sound, altitude, air quality, pollen count, humidity,environmental pressure, and time of day.
 7. The system of claim 1,wherein the device includes a wellness monitoring device within anadvanced patient management system.
 8. The system of claim 1, whereinthe sensed respiration acquired from the implantable medical deviceincludes a sensed parameter related to instantaneous lung volume from atrans-thoracic sensor.
 9. A system for monitoring a heart failure statusof a heart failure patient, comprising: an implantable medical device;and a programmable device having machine executable instructions forperforming a method to assist with managing a patient's health, themethod comprising: acquiring from the implantable medical device a heartrate parameter and a parameter related to instantaneous lung volume; andgenerating a composite parameter indicative of respiratory sinusarrhythmia (RSA) using the heart rate parameter and the parameterrelated to instantaneous lung volume.
 10. The system of claim 9, whereinthe device includes a wellness monitoring device within an advancedpatient management system.
 11. The system of claim 9, wherein, in themethod performed by the programmable device, acquiring the patientcontext or environmental context includes acquiring a patient contextselected from the group of patient contexts consisting of posture,activity level, sleep/wake state, and mental/emotional state.
 12. Thesystem of claim 9, wherein the method performed by the programmabledevice includes acquiring an environmental context selected from thegroup of environmental contexts consisting of temperature, sound,altitude, air quality, pollen count, humidity, environmental pressure,and time of day.
 13. The system of claim 9, wherein the system includesa display and the method performed by the programmable device includesdisplaying one or more trends of the composite parameter on the display.